Common Rule Revisions

The resources below were developed to help the Ohio State human subjects research community understand the revisions to the Common Rule that went into effect on January 21, 2019. Please check back often as updates will be made on an ongoing basis.

What the Final Rule Changes Mean for Your Research

On January 21, 2019, the Common Rule regulatory changes (hereafter, “Final Rule”) went into effect for all new research reviewed and approved by one of The Ohio State University IRBs or for exempt review. Below you will find highlights of what you need to know: (For more details organized by topic, click the links above.)

There is no phase-in period. Any study approved on or before January 20, 2019, must comply with the Pre-2018 Rule, and any study approved on or after January 21, 2019, must comply with the Final Rule.

Buck–IRB has been updated to accommodate both the Pre-2018 Rule and Final Rule requirements. Refer to the list of updates to the Buck-IRB system for more details.

Informed consent changes: The Final Rule contains several major revisions to the requirements for informed consent. Refer to the Common Rule Revisions: Informed Consent page for more information.

All new studies must use Ohio State’s updated consent templates to develop informed consent documents. The templates integrate the new required and additional elements of informed consent.

The Final Rule requires consent materials to address whether participants’ de-identified data and/or biospecimens may be used and/or distributed for future research purposes without additional consent. Consequently, investigators should consider such potential uses at the beginning of the study and draft the consent form accordingly. We anticipate that most investigators will want to allow for future use, even if they have no concrete plans for doing so.

Investigators conducting federally funded clinical trials should plan ahead for compliance with the new requirement to post an IRB-approved version of the consent form to a federal website, such as ct.gov. The consent form should be posted after recruitment closes, but no later than 90 days after the last study visit.

Annual review: The Final Rule eliminates continuing review by the IRB for many minimal risk, non-FDA-regulated studies. For qualifying studies, Ohio State will require an annual check-in via an annual status report, an abbreviated version of the continuing review application that is confirmed administratively by ORRP staff. Refer to the Common Rule Revisions: Continuing Review page for more information.

Exemptions: Some studies that would have required expedited IRB review under the Pre-2018 Rule may qualify for exemption under the Final Rule. If your new study qualifies for exemption under the Final Rule, you may still wish to submit the project as a non-exempt study, depending on the project’s projected length and variability.

The exempt application is significantly shorter than an initial IRB submission form, but the study will remain active in Buck-IRB for only three years; if the study continues beyond that point, a new exempt application must be submitted. In addition, only personnel changes are permitted for exempt studies. Amendments to any study materials and/or activities require a new exempt submission. Exempt studies do not require annual check-ins via an annual status report.

Submitting a non-exempt study for expedited review requires more work up front, but allows for more flexibility over the life of the study. Non-exempt studies may be kept active indefinitely, and amendments may be submitted at any time. In most cases, the annual check-in requirement can be satisfied by submitting an annual status report.